RecruitingPhase 2Phase 3NCT01790061

Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis

Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

500 participants

Start Date

Feb 1, 2013

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis Microbiota Inflammatory Bowel Disease Fecal Microbiota Transplantation Bacteria

Summary

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Eligibility

Min Age: 6 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a standardized version of fecal microbiota transplantation (FMT) — a procedure that transfers gut bacteria from a healthy donor into a patient's gut — as a treatment for ulcerative colitis (UC), a chronic inflammatory bowel condition. **You may be eligible if...** - You have been diagnosed with ulcerative colitis for at least 3 months (confirmed by a combination of symptoms, bowel scope, and biopsy) - Previous treatments for your UC have not worked well enough **You may NOT be eligible if...** - You have another serious illness, such as cancer, heart or lung failure, or severe liver or kidney disease - You have a gut infection caused by the bacteria Clostridioides difficile - You are unwilling to attend follow-up visits - You have previously had FMT or a related procedure (washed microbiota transplantation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandardized FMT

Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon

DRUGTraditional treatments

Medications

Locations(1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT01790061

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